Given the complexities of surgical procedures and the various tools, instruments, implants and other devices used in the procedures, as well as the varying anatomical differentiation between patients who receive those tools, instruments, implants and devices, it is often challenging to create a surgery plan that accounts for the unique and sometimes irregular anatomical features of a particular patient. For example, the implantation of pedicle screws in a vertebral body (as a adjunct or stand-alone stabilization mechanism) is well accepted amongst surgeons who treat various spine pathologies, and although the performance of various pedicle screw constructs have become predictable, there are still multiple challenges with the placement and insertion of the pedicle screws or other bone anchors. The challenges occur when a surgeon is unable to reference bony landmarks due to previous surgery or when the patient's anatomy is irregular in shape.
As a result of these challenges, efforts have been made to develop technologies that assist the surgeon with the insertion, placement and/or alignment of individual instruments and/or implants that rely on pre-operative planning in conjunction with real time image-guided systems. One such system is disclosed in WIPO Publication No. WO 2008027549 to Crawford et al., which includes use of modeling anatomical features of a patient in conjunction with a haptic interface to simulate a surgical procedure in a pre-operative setting. Although systems like the one disclosed by Crawford et al. offer visual assistance with the placement of instruments and implants, the simulations are time-consuming and impractical for a number of surgical procedures. Furthermore, these systems rely on technologies that have not been widely accepted due in part to the cost of the technologies, and provide several intra-operative challenges, such as overreliance on engineering for fabricating each anatomical model and analytical analysis of those models, which most surgeons wish to avoid.
Surgeons now have the ability to readily convert magnetic resonance imaging (MRI) data or computed tomography (CT) data into a data set readable by computer-aided design (CAD) program and/or finite element modeling (FEM) program, which then may be used to create, for example, a custom implant based on the dynamic nature of the anatomical structures the custom implant is designed to associate with. This data, while currently used by surgeons in surgery planning, is largely unused for creating a customized set of instruments or other surgical devices that are designed to complement the patient's unique anatomy. Others have used this data to create, for example, a user-defined surgical guide for making an incision in the desired location, as is disclosed in U.S. Publication No. 20080114370 to Schoenefeld. However, Schoenefeld discloses a surgical guide that only partially penetrates the subcutaneous portion of the patient's anatomy (i.e., only a small portion of the guide is inserted through the incision, while the main body of the guide remains external to the incision). Furthermore, the guide disclosed in Schoenefeld uses only a limited number of unique data points to match the guide with the patient's anatomy, and thus may easily become misaligned or improperly oriented during the surgical procedure. Schoenefeld also fails to disclose customized apparatus manufactured by rapid prototyping equipment that not only matches an anatomical feature of the patient, but also matches one or more other apparatus used in the surgical procedure, such as a customized tool or instrument or one additional surgical guide, for example.
The prior art also fails to teach a system for creating a suite of surgical apparatus based on the data set derived from the MRI or CT scan. For example, the use of the patient specific data set for a vertebral body may allow a surgeon to accommodate for subtle variations in the position and orientation of plate to avoid particular bony anatomy or irregularities in the positioning and alignment of the adjoining vertebral bodies. As another example, the use of these data sets may also assist a surgeon in selecting a desired trajectory for an implantable device so as to avoid, for example, crossing the pedicle wall and violating the spinal canal during an actual procedure. The use of the data sets permit the surgeon to avoid these types of mistakes by creating customized tools and instruments, which may comprise end-stops or other safety related features to avoid over-torque and over-insertion of any implantable devices. The data sets also permit the surgeon to create a patient-contacting surface that is oriented to match one or more of the anatomical features represented by the data set, and thereby quickly and efficiently locate and place the patient-contacting surface(s) in the appropriate location and orientation.
It would therefore be advantageous to provide apparatus suitable for use with a surgical procedure that is adapted and/or configured and/or capable of conforming to a plurality of anatomical features of a particular patient and/or to one or more additional apparatus to assist the surgeon in completing the surgical procedure(s) safely and efficiently, and that otherwise significantly reduces, if not eliminates, the problems and risks noted above. Other advantages over the prior art will become known upon review of the Summary and Detailed Description of the Invention and the appended claims.